PharmaLex

Regulatory Affairs (BB-E3F62)

Gefunden in: Neuvoo AT

Beschreibung:

Your Job

  • Provide a wide range of flexible regulatory affairs services for different clients on a range of product types (i.e. chemicals, biologicals, generics, medical devices) and therapeutic areas
  • Planning and conducting authorization procedures in the EU (MRP, DCP, CP and purely national procedures, CTA) as well as lifecycle management procedures (variations, renewals, MAH transfers, etc.)
  • Review of approval documents and text management (labeling management)
  • QC review of documentation, compendial cross checking and report formatting
  • Ensuring that regulatory affairs programs and projects are delivered to high standards.
  • Communication in the project team, with clients, local partners and representatives in the international context
  • Providing regulatory expertise to regulatory programs and projects
  • Professional interaction with regulatory authorities
  • Accurate time reporting.
  • Given the nature of the role, some EU and international travel can be expected, including on site availability on clients’ sites.

  • Your Profile

  • Degree in natural sciences (preferably medicine, pharmacy, chemistry or biology)
  • Required level of experience depending on client project
  • Experience in drug licensing with a focus on EU or with admission procedures in non-EU countries and experience with Launch Management, Labelling Management, Clinical Trial Applications and admission procedures in non-EU countries.
  • Knowledge of current drug and regulatory requirements (EU)
  • Experience in a multi-task consulting environment
  • IT affinity to databases and the handling of project management software
  • Team-oriented, communicative, conscientious, accurate and responsible
  • Home based, flexibility to travel and work on site
  • Secure MS Excel and Word knowledge as well as confident English and French skills
  • Structured, analytical, systematic thinker
  • Strong communication skills
  • Concentrated and high-quality work
  • Ability to work in a team
  • Strong sense of responsibility
  • Excellent written and verbal communication skills, with a focus on client-facing interactions
  • Language: fluency in English is a must

  • calendar_todayvor 5 Tagen

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